L'étude NOTICE : Étude d'évaluation de la communication en neurochirurgie et en orthopédie après des fusions lombaires (NOTICE)
The purpose of this single-blind, randomized, controlled study is to assess the efficacy of "informative text messages" vs "traditional handouts" provided to lumbar spine surgery patients post-operatively.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
A total of 224 adult patients (18 years or older) undergoing spinal fusion surgery at Duke University Hospital, will be recruited from the Duke Department of Neurosurgery and the Duke Department of Orthopedics. Participants will be consented and will complete standard of care outcomes questionnaires (Visual Analogue Scale, Oswestry Disability Index and Euro-Quol 5D) at the pre-operative clinic visit for baseline comparison. Participants will be randomized, through REDCap, with equal probability to either: A) the control group, with standard post-surgery handouts, or B) the experimental group, which will receive text messages for a period of 2 weeks after surgery (daily for the first week, and every other day for the second week). Text messages were designed to be standardized and automated, with an embedded link to a video regarding at-home, post-surgery-care instructions. Patients will be directed not to respond to the text messages, but to call for any questions or concerns. The primary outcome will be a reduction in 30-days post-surgery readmission rates. The secondary outcomes will be a reduction in 30-days post-surgery ED visits rates, back and leg pain scores, and anxiety levels. These outcomes will be assessed via a phone interview at 30-days (up to max of 37 days) post-discharge for both groups.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Claudia E Pamanes, MPH
- Numéro de téléphone: (919) 668-0897
- E-mail: claudia.pamanes@duke.edu
Lieux d'étude
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North Carolina
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Durham, North Carolina, États-Unis, 27710
- Recrutement
- Duke Neurosurgery and Duke Orthopedics
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Contact:
- Claudia E Pamanes, MPH
- Numéro de téléphone: (919) 668-0897
- E-mail: claudia.pamanes@duke.edu
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Contact:
- Beth Perry, RN, CCRP
- Numéro de téléphone: (919) 681-2695
- E-mail: beth.perry@duke.edu
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Chercheur principal:
- Oren N Gottfried, MD FAANS
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
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Primary lumbar fusion 1-4 levels
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18 years or older
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Degenerative spine diagnosis
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Answers YES to all the following screening questions:
- Do you own a mobile phone that is capable of sending and receiving text messages?
- Do you know how to text and feel comfortable texting?
- Are you a regular (at least once a day) text-message user?
- Are you agreeable to regular contact?
Exclusion Criteria:
- Prior lumbar fusions
- Tumors/infection/trauma
- Prisoners or institutionalized patients
- Non-English speaking patients
- Patients who smokes or with uncontrolled diabetes
- Participants will be removed from study if discharged to a rehabilitation center or discharged beyond 7 days post-operatively (we are expecting ~15% of patients to be discharged to a rehabilitation center or discharged beyond 7 days post-operatively)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: ARM 1: Text Message Group
The intervention group will receive automated text messages every day for the first week, and every other day for the second week post-operatively. The text messages will follow a series of pre-defined standardized scripts (Appendix 3) with embedded hyperlinks to a video from the providers with further advice. The patient is directed not to respond to the text messages, but to call for any questions or concerns. The text message group will receive a 30-day post-operative phone call to evaluate: number of ED visits, hospital readmissions, and to re-administer the questionnaires completed at baseline visit. Other data to be collected may include the following: number of phone calls to provider, MyChart messages to provider, pain medications, and new problems like pain and infection. |
The intervention group will receive automated text messages every day for the first week, and every other day for the second week post-operatively. The text messages will follow a series of pre-defined standardized scripts (Appendix 3) with embedded hyperlinks to a video from the providers with further advice. The patient is directed not to respond to the text messages, but to call for any questions or concerns. The text message group will receive a 30-day post-operative phone call to evaluate: number of ED visits, hospital readmissions, and to re-administer the questionnaires completed at baseline visit. Other data to be collected may include the following: number of phone calls to provider, MyChart messages to provider, pain medications, and new problems like pain and infection.
Autres noms:
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Aucune intervention: ARM 2: Control group
The control group will be given the standard post-op packet that includes detailed instructions on proper wound care and signs and symptoms of infection. They will not receive text messages. The same outcomes will be assessed in both groups through a 30-day post-operative phone call. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in readmission rates within 30 days post-lumbar spine surgery.
Délai: Baseline, 30 days
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Change in readmission rates within 30 days post-lumbar spine surgery as measured by questionnaire. |
Baseline, 30 days
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Emergency Department (ED) visit rates within 30 days post-lumbar spine surgery.
Délai: Baseline, 30 days
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Change in Emergency Department (ED) visit rates within 30 days post-lumbar spine surgery as measured by questionnaire. |
Baseline, 30 days
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Change in back and leg pain levels within 30 days post-lumbar spine surgery as measured by "Oswestry Disability Index" (ODI) questionnaire.
Délai: Baseline, 30 days
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ODI questionnaire is a tool to evaluate a subjective level of functional disability in daily living activities in patients with low back pain. Scores go from 0% (no disability) to 100% (maximum disability possible). |
Baseline, 30 days
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Change in anxiety/depression levels within 30 days post-lumbar spine surgery as measured by "European Quality of Life-5 Dimension" (EQ-5D) questionnaire.
Délai: Baseline, 30 days
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The EQ-5D is an instrument to quantify health-related quality of life. Scores can be reported as a five digit number in a range from 11111 (full health) to 55555 (worst health). |
Baseline, 30 days
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in patient satisfaction levels within 30 days post-lumbar spine surgery.
Délai: Baseline, 30 days
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Change in patient satisfaction levels within 30 days post-lumbar spine surgery as measured by questionnaire. |
Baseline, 30 days
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Oren N Gottfried, MD FAANS, Duke Neurosurgery
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Pro00103904
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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